A large-scale study of medical claims data shows that introducing sophisticated biologic therapies early in the course of treatment for Crohn's disease improves response to medication and reduces the need for surgery.

There is no known cure for Crohn's disease, and traditional treatment is focused on a step-up strategy of managing inflammatory symptoms, starting with simpler and less costly oral medications such as aminosalicylates (5-ASAs) and corticosteroids, and escalating through a series of steps to more expensive biological therapies that target specific proteins in the immune system's inflammatory response.

David Rubin, MD, associate professor of medicine and co-director of the University of Chicago Medicine's Inflammatory Bowel Disease Center, studied a newer top-down strategy that reverses this order of treatment. He found that patients treated with biologic therapies earlier were significantly less likely to need steroids, lose response to their biologic therapy, and require surgery related to their Crohn's disease. We're essentially reversing the management strategy in Crohn's disease, Rubin said.

He emphasized that the medications often used first for patients with Crohn's are also the least effective and carry risks for side effects. We've long discussed and debated that 5-ASAs don't work in the majority of Crohn's patients, and certainly don't change any outcomes, he said. Steroids are ineffective long-term and are also dangerous because they have significant side effects such as infections.

Crohn's is a disorder in which the body's immune system appears to have lost the ability to regulate itself and becomes overactive, causing progressive damage to the bowel structure and function. Patients often need bowel surgery to repair this damage. Researchers have made great progress finding genetic and environmental contributors to Crohn's disease, but the actual cause is unknown.

Rubin said that physicians have questioned the effectiveness of the step-up strategy because patients experience little relief while being treated with medications before they receive the biological therapies. During that time, they suffer from active disease, have low rates of remission and often appear to lose response to the biological therapies.

In recent years a treatment strategy that starts with the targeted biologic therapy as a first option has been explored in controlled clinical trials. The encouraging results suggested that such an approach results in higher remission rates. However, it was not clear whether this top-down approach would translate to the general population of patients with Crohn's disease, or whether such an approach would maintain the response to biologic therapy and decrease the need for surgery.

The Food and Drug Administration approved the first targeted biologic therapy for Crohn's disease in 1998 and the second two in 2007 and 2008. Rubin said physicians are hesitant to prescribe them earlier because they are expensive, must be administered through injections instead of pills and are typically saved until last,. Patients and doctors are nervous about immune suppressive therapies. The perception in the current treatment algorithm is that the therapies saved for last must also be the most dangerous, he said. But that's the wrong thinking, and by delaying their prescription it may be a self-fulfilling prophecy because by then patients have suffered more damage to their bowels and are less likely to respond favorably.